Bacterial Conjunctivitis
Conditions
Keywords
Bacterial Conjunctivitis
Brief summary
The primary objective of this study is to investigate the initial antibiotic effects in the treatment of bacterial conjunctivitis symptoms in subjects one year of age and older.
Interventions
DRUGVigamox Ophthalmic Solution
Moxifloxacin 5mg/mL 3 times daily for 7 days
DRUGBSS placebo
Balanced Saline Solution for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
Sponsors
Topical Solutions Ltd.
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis in one or both eyes of bacterial conjunctivitis based on: * symptoms less than or equal to 24 hours prior to first visit * rating \> or equal to 1 for bulbar conjunctival injection * must have a rating \> 1 for conjunctival discharge / exudate in at least one eye (the same eye as bulbar conjunctival injection ) at Visit 1, and 2. Must experience some matting in the affected eye(s). 3. 1 year of age or older, of any race and either sex 4. Able to understand and sign an informed consent that has been approved by an Institutional Review Board; or if the subject is a minor, the informed consent must be signed and understood by the subjects legally authorized representative (parent or guardian). Assent to participate should be obtained from subjects 6 years of age or older unless not allowed by local regulation. 5. Must agree to comply with study visit schedule, photographs and other study requirements. If subject is a minor, the parent or guardian must agree to ensure compliance.
Exclusion criteria
1. Cannot have had bacterial conjunctivitis as reported by subject (or parent if subject is a minor) for \> 24 hours. 2. Any current lid disease on clinical examination. 3. Known or suspected allergy or hypersensitivity to fluoroquinolones. 4. Suspected fungal, viral (e.g. Herpes simplex) or Acanthamoeba infection, based on clinical observation. 5. Any systemic or ocular disease or disorder, complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study (e.g., hepatitis, acute or chronic renal insufficiency). 6. Use of topical ocular medications during the study period. 7. Antibiotics (systemic or topical) may not be used within 7 day of visit 1 or anytime after this visit for the duration of the study. 8. Women of childbearing potential not using reliable means of birth control. 9. Women who are pregnant or lactating. 10. Enrollment of more than one person per household at the same time. 11. Enrollment of the investigator or his or her staff, family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals. 12. Participation in any investigational drug or device study within 30 days of entering this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exploratory Outcomes From Digital Photography | 24 hours after administration of first dose | Photographs were taken before and after treatment. Outcome is the number of patients whose photographs showed a subjective visual change based upon an exploratory review of patient photographs in signs of bacterial conjunctivitis before and after treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exploratory Evaluation of Changes in Ocular Signs and Symptoms | Baseline (Day 1) to Day 2 | Number of patients who had clinical resolution (0 on all scales below) from baseline (Day 1) to Day 2 in ocular and symptoms of bacterial conjunctivitis: Bulbar Conjunctival Injection - 0 (none) to 4 (Severe) scale. Conjunctival Discharge (Mucopurulent) - 0 (none) to 3 (Severe) scale. Lid Erythema - 0 (none) to 3 (Severe) scale. Lid Swelling - 0 (none) to 3 (Severe) scale. Palpebral Conjunctiva - 0 (none) to 3 (Severe) scale. Foreign Body Sensation - 0 (none) to 3 (Severe) scale. Tearing - 0 (none) to 3 (Severe) scale. Photophobia - 0 (none) to 3 (Severe) scale. |
| Microbiological Culture Evaluation/Eradication Percent - Enterobacter Faecalis and Candida Albicans | 24 hours after administration of first dose | Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1 |
| Microbiological Culture Evaluation/Eradication Percent - Eradication of All Other Isolates and Corynform-like | 24 hour after administration of first dose | Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1 |
| Microbiological Culture Evaluation/Eradication Percent - Staphylococcus Aureus, Steptococcus Pneumoniae, and Enterobacter Cloacae | 24 hours after administration of first dose | Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vigamox Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days | 17 |
| Placebo Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days | 7 |
| Total | 24 |
Baseline characteristics
| Characteristic | Vigamox | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 7 Participants | 7 Participants | 14 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 0 Participants | 10 Participants |
| Sex: Female, Male Female | 11 Participants | 5 Participants | 16 Participants |
| Sex: Female, Male Male | 6 Participants | 2 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 7 |
| serious Total, serious adverse events | 0 / 17 | 0 / 7 |
Outcome results
Primary
Exploratory Outcomes From Digital Photography
Photographs were taken before and after treatment. Outcome is the number of patients whose photographs showed a subjective visual change based upon an exploratory review of patient photographs in signs of bacterial conjunctivitis before and after treatment.
Time frame: 24 hours after administration of first dose
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vigamox | Exploratory Outcomes From Digital Photography | 17 Participants |
| Placebo | Exploratory Outcomes From Digital Photography | 7 Participants |
Secondary
Exploratory Evaluation of Changes in Ocular Signs and Symptoms
Number of patients who had clinical resolution (0 on all scales below) from baseline (Day 1) to Day 2 in ocular and symptoms of bacterial conjunctivitis: Bulbar Conjunctival Injection - 0 (none) to 4 (Severe) scale. Conjunctival Discharge (Mucopurulent) - 0 (none) to 3 (Severe) scale. Lid Erythema - 0 (none) to 3 (Severe) scale. Lid Swelling - 0 (none) to 3 (Severe) scale. Palpebral Conjunctiva - 0 (none) to 3 (Severe) scale. Foreign Body Sensation - 0 (none) to 3 (Severe) scale. Tearing - 0 (none) to 3 (Severe) scale. Photophobia - 0 (none) to 3 (Severe) scale.
Time frame: Baseline (Day 1) to Day 2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vigamox | Exploratory Evaluation of Changes in Ocular Signs and Symptoms | 17 Participants |
| Placebo | Exploratory Evaluation of Changes in Ocular Signs and Symptoms | 7 Participants |
Secondary
Microbiological Culture Evaluation/Eradication Percent - Enterobacter Faecalis and Candida Albicans
Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1
Time frame: 24 hours after administration of first dose
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vigamox | Microbiological Culture Evaluation/Eradication Percent - Enterobacter Faecalis and Candida Albicans | Enterobacter faecalis | 17 Percent bacteria eradicated |
| Vigamox | Microbiological Culture Evaluation/Eradication Percent - Enterobacter Faecalis and Candida Albicans | Candida albicans | 75 Percent bacteria eradicated |
| Placebo | Microbiological Culture Evaluation/Eradication Percent - Enterobacter Faecalis and Candida Albicans | Enterobacter faecalis | 100 Percent bacteria eradicated |
| Placebo | Microbiological Culture Evaluation/Eradication Percent - Enterobacter Faecalis and Candida Albicans | Candida albicans | 0 Percent bacteria eradicated |
Secondary
Microbiological Culture Evaluation/Eradication Percent - Eradication of All Other Isolates and Corynform-like
Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1
Time frame: 24 hour after administration of first dose
Population: No patients in the Placebo group had Corynform-like bacteria (or other types of bacteria) identified at Day 1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vigamox | Microbiological Culture Evaluation/Eradication Percent - Eradication of All Other Isolates and Corynform-like | Eradication of all other isolates | 100 Percent bacteria eradicated |
| Vigamox | Microbiological Culture Evaluation/Eradication Percent - Eradication of All Other Isolates and Corynform-like | Corynform-like | 0 Percent bacteria eradicated |
Secondary
Microbiological Culture Evaluation/Eradication Percent - Staphylococcus Aureus, Steptococcus Pneumoniae, and Enterobacter Cloacae
Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1
Time frame: 24 hours after administration of first dose
Population: No patients in the Vigamox group had Staphylococcus aureus, Steptococcus pneumoniae, or Enterobacter cloacae identified at Day 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Microbiological Culture Evaluation/Eradication Percent - Staphylococcus Aureus, Steptococcus Pneumoniae, and Enterobacter Cloacae | Staphylococcus Aureus | 0 Percent bacteria eradicated |
| Placebo | Microbiological Culture Evaluation/Eradication Percent - Staphylococcus Aureus, Steptococcus Pneumoniae, and Enterobacter Cloacae | Steptococcus Pneumoniae | 50 Percent bacteria eradicated |
| Placebo | Microbiological Culture Evaluation/Eradication Percent - Staphylococcus Aureus, Steptococcus Pneumoniae, and Enterobacter Cloacae | Enterobacter Cloacae | 67 Percent bacteria eradicated |